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Device received FDA approval
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Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. The Extubation Readiness Test (ERT) is a simple evaluation commonly performed in the intensive care unit to determine if a child is ready to have the breathing tube removed.
The purpose of this study is to better understand how the ERT and the eventual removal of the breathing tube affect where the air is in the lungs, and whether this can help predict which children will succeed or fail having the breathing tube taken out. This can done be at the bedside with a device called electrical impedance tomograph. This novel device is painless and uses a belt fitted with sensors placed around the chest to show where the air is in the lungs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICU and PCICU Patients | Experimental | Patients younger than 17 years of age receiving mechanical ventilation for an acute respiratory illness will be approached to participate prior to initiation of an ERT for clinical purposes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENLIGHT 2100 ventilatory electrical impedance tomograph | Device | The ENLIGHT 2100 system will remain connected to the patient for data acquisition from immediately prior to initiation of the ERT until up to 24 hours following extubation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in expiratory lung volume as measured by global lung electrical impedance | Baseline, 60 mins, 75 mins, 90 mins |
| Measure | Description | Time Frame |
|---|---|---|
| Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance | Baseline, 60 mins, 75 mins, 90 mins | |
| Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance | Baseline, 60 mins, 75 mins, 90 mins |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Rotta, MD, FCCM | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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| Percent of failed extubation as measured by need for re-intubation | Within 24 hours |